A Study of ZG005 in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumors
- Interventions
- Biological: ZG005 Powder for Injection
- Registration Number
- NCT06233292
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 484
- Fully understand the study and voluntarily sign the informed consent form.
- Male or female 18-70 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
- Life expectancy ≥ 3 months;
- Histologically or cytologically confirmed diagnosis of advanced solid tumors.
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
- Any other malignancy within 5 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy ZG005 Powder for Injection The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma Part 1: Dose Escalation ZG005 Powder for Injection The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).
- Primary Outcome Measures
Name Time Method Adverse Event (AE) Up to 24 Months Number of participants with adverse events that are related to treatment
Dose Limiting Toxicities (DLT) Up to 21Days A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause.
Objective Response Rate Up to 24 Months Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Maximum tolerated dose (MTD) Up to 24 Months During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China